Implementation of Machine Learning and Hemodynamic Profiles Based Clinical Decision Support Systems for Personalized Guideline Accordant Antihypertensive Regimens in Primary Care: a Pragmatic Cluster Randomized Controlled Trial

NCT06828692 | Recruiting

• 1 other identifier: NCRCSZ-2023-014
• Study Type: interventional
• Target: 2,160
• Locations: 1 country
• Sites: 1

Brief Summary

This trial is a prospective, multicenter, single-blind, three-arm parallel-group, cluster randomized controlled trial assessing the effectiveness and safety of two types of CDSS in primary care settings in China. Primary care sites are randomized to one of the intervention arms or the control arm (1:1:1 ratio) using computer-generated random numbers stratified by region and administrative categories of the primary healthcare institutions (including community health centers, community health stations, and township health centers). A total of 51 primary care sites are randomized to three groups, with 17 sites assigned to group A (use a CDSS based on clinical guidelines and machine learning), 17 sites to group B (use a CDSS based on guidelines, hemodynamic parameters and ML), and the remaining 17 sites to the control group.

Conditions

Hypertension

Keywords

Hypertension; CDSS; cluster randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• hierarchical composite outcome

  The primary outcome of the trial is a hierarchical composite outcome, evaluated using the Win-ratio method in the following order: 1. Office blood pressure control rate (\<130/80 mmHg) at 3 months after randomization. 2. The duration from baseline to the first occurrence of controlled blood pressure achievement (\<130/80 mmHg) within 3 months after randomization. 3. The composite index of the number and dosage of antihypertensive drugs among participants achieved controlled blood pressure at 3 months after randomization.

  Baseline; 3 months

Secondary Outcomes (5)

• Separate evaluation of each component of the three-tier hierarchical composite primary outcome at 3 months

  Baseline; 3 months

• Changes in office systolic and diastolic blood pressure from baseline to 1 month and 3 months

  Baseline; 1 month; 3 months

• Average 24-hour ambulatory systolic and diastolic blood pressure, along with blood pressure control rate at 3 months

  3 months

• Changes in hemodynamic parameters measured by ICG from baseline to 3 months

  Baseline; 3 months

• Differences in the three-tier hierarchical composite primary outcomes and each component of the three-tier hierarchical composite primary outcome among intervention groups at 3 months

  Baseline; 3 months

Other Outcomes (1)

• safety outcome

  Baseline; 3 months

Study Arms (3)

Group A (CG+ML)

EXPERIMENTAL

Combination Product: Group A (clinical guideline+machine learning)

Group B (CG+ICG+ML)

EXPERIMENTAL

Combination Product: Group B (clinical guideline+impedance cardiograph+machine learning)

Group C (UC)

OTHER

Other: Group C (usual care)

Interventions

Group C (usual care) OTHER

Control group, the physicians manage the hypertensive patients according to their knowledge and experiences.

Group C (UC)

Group A (clinical guideline+machine learning) COMBINATION_PRODUCT

Group A (CG+ML): A Clinical Decision Support System (CDSS) with the algorithm that incorporates clinical guideline (CG) and machine learning (ML) approach.

Group A (CG+ML)

Group B (clinical guideline+impedance cardiograph+machine learning) COMBINATION_PRODUCT

Group B (CG+ICG+ML): A Clinical Decision Support System (CDSS) with the algorithm that incorporates clinical guideline (CG), hemodynamic parameters measured by impedance cardiograph (ICG), and machine learning (ML) approach.

Group B (CG+ICG+ML)

Eligibility Criteria

• Age: 35 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≤ Age \< 80 years.
• Regularly attend the clinic for hypertension treatment during the study period, without plans of traveling during the study period.
• Diagnosed with hypertension, with SBP ≥140mmHg at screening.
• Currently taking 0 or 2 classes of antihypertensive medications (A/C/D), with or without concurrent use of class B.
• Willing to participate in the trial and capable of providing written informed consent.

You may not qualify if:

• Physician-diagnosed or suspected secondary hypertension (e.g., hypertension caused by renal disease, renal artery stenosis, aortic stenosis, primary aldosteronism, pheochromocytoma/paraganglioma, Cushing's syndrome, thyroid dysfunction, intracranial disease, drug-induced, or rare monogenic genetic disease).
• SBP ≥180mmHg and/or DBP ≥110mmHg at the screening visit.
• Suspected or diagnosed white coat hypertension.
• History of coronary heart disease.
• History of heart failure.
• Intolerance to 2 or more classes of A, C,D antihypertensive medications.
• Currently taking antihypertensive medications other than class A,B,C and D.
• Diagnosed chronic kidney disease, estimating Glomerular Filtration Rate (eGFR)\< 60 ml/min·1.73m2, or receiving dialysis.
• Serious medical conditions (e.g., malignant cancer and hepatic dysfunction)
• Currently in an acute episode of disease (e.g, new-onset cardiovascular and cerebrovascular disease occurred within 3 months).
• Cognitive or communicative disorders.
• Currently pregnant or breastfeeding or planning a pregnant or breastfeeding during the study.
• Reluctant to take antihypertensive medications or have poor compliance with previous treatment.
• Participating in other clinical trials.

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead

Study Sites (1)

Fuwai Shenzhen Hospital, Chinese Academy of Medical Sciences

Shenzhen, Shenzhen, China

RECRUITING

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Xin Zheng

  Fuwai Hospital, China Academy of Medical Sciences, National Center for Cardiovascular Diseases

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaofang Yan

CONTACT

0086 10 60686871; yanxiaofang@fuwai.com

Xin Zheng

CONTACT

0086 10 60866719; zhengxin@fuwai.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2025
• First Posted: February 14, 2025
• Study Start: May 26, 2025
• Primary Completion: February 28, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: February 12, 2026

Record last verified: 2026-02

Locations

CN (1)